Food

DMBA in Dietary Supplements

DMBA is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, for dietary supplements that contain DMBA to be lawfully marketed, one of the following must apply:

(1) the product containing the dietary ingredient must contain only dietary ingredients that have been present in the food supply as an article used in food in a form in which the food has not been chemically altered, or
(2) there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended in the product labeling, will reasonably be expected to be safe; and prior to bringing the products to market, the manufacturer or distributor must notify FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably expected to be safe.

Because neither of these conditions has been met by those marketing products that contain or are labeled as containing DMBA as a dietary ingredient, the FDA considers these dietary supplements to be adulterated.

DMBA is also known as:

  • 1,3-Dimethylbutylamine
  • 2-Amino-4-Methylpentane Citrate
  • 4-Amino-2-Methylpentane Citrate
  • 4-Amino Methylpentane Citrate
  • Amperall
  • AMP
  • AMP Citrate
  • 4-AMP Citrate
  • 4-Methyl-2-Pentanamine

Recent FDA Action on Dietary Supplements Labeled as Containing DMBA

April 2015

On April 28, 2015, the FDA issued warning letters to 14 companies regarding a total of 17 products for which the product labeling identifies DMBA as a dietary ingredient.

The FDA considers these products to be adulterated because they are labeled as containing a new dietary ingredient, DMBA, and because they have not satisfied the conditions described above to include DMBA as a dietary ingredient.

Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated or misbranded.

The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law. The warning letters also caution the companies that the FDA may take further enforcement action without warning if they do not immediately cease distribution of the products.

The agency will continue to update this page in the event additional actions are taken related to DMBA.

Warning Letters:

 

Page Last Updated: 04/28/2015
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